H.G.M. Leufkens

Universiteit Utrecht, Utrecht, Utrecht, Netherlands

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Publications (343)615.47 Total impact

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    ABSTRACT: The risk of a subsequent major or any fracture after a hip fracture and secular trends herein were examined. Within 1 year, 2.7 and 8.4 % of patients sustained a major or any (non-hip) fracture, which increased to 14.7 and 32.5 % after 5 years. Subsequent fracture rates increased during the study period both for major and any (non-hip) fracture.
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    ABSTRACT: Drug utilization studies have applied different methods to various data types to describe medication use, which hampers comparisons across populations. The aim of this study was to describe the time trends in antidepressant prescribing in the last decade and the variation in the prevalence, calculated in a uniform manner, in seven European electronic healthcare databases. Annual prevalence per 10,000 person-years (PYs) was calculated for 2001-2009 in databases from Spain, Germany, Denmark, the United Kingdom (UK), and the Netherlands. Prevalence data were stratified according to age, sex, antidepressant type (selective serotonin re-uptake inhibitors [SSRIs] or tricyclic antidepressants [TCAs]) and major indications. The age- and sex-standardized prevalence was lowest in the two Dutch (391 and 429 users per 10,000 PYs) and highest in the two UK (913 and 936 users per 10,000 PYs) populations in 2008. The prevalence in the Danish, German, and Spanish populations was 637, 618, and 644 users per 10,000 PY respectively. Antidepressants were prescribed most often in 20- to 60-year-olds in the two UK populations compared with the others. SSRIs were prescribed more often than TCAs in all except the German population. In the majority of countries we observed an increasing trend of antidepressant prescribing over time. Two different methods identifying recorded indications yielded different ranges of proportions of patients recorded with the specific indication (15-57 % and 39-69 % for depression respectively). Despite applying uniform methods, variations in the prevalence of antidepressant prescribing were obvious in the different populations. Database characteristics and clinical factors may both explain these variations.
    European Journal of Clinical Pharmacology 05/2014; · 2.74 Impact Factor
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    ABSTRACT: The aim of this study was to evaluate fracture risk in patients with Guillain-Barré syndrome (GBS). No association with risk of fracture was observed for GBS patients compared with controls. Only GBS patients using pain treatment had a doubled risk of fracture. Symptoms of Guillain-Barré syndrome (GBS) may vary from mild difficulty in walking to complete paralysis, which may increase the risk of fractures. Therefore, the aim of this study was to evaluate fracture risk in patients with GBS. We conducted a retrospective cohort study using the UK Clinical Practice Research Datalink (1987-2012). Each patient with GBS was matched by year of birth, sex, and practice, up to six patients without a history of GBS. Outcome measure was any fracture. There were no associations between GBS and any fracture, adjusted hazard ratio (AHR) 1.01 (95 % confidence interval [CI] 0.77-1.33), or osteoporotic fracture, AHR 0.76 (95 % CI 0.50-1.17), compared with controls. Stratification to gender, age, and duration since diagnosis did not show an association either. Only for GBS patients using pain treatment, risk of fracture was doubled AHR 1.97 (95 % confidence CI 1.21-3.21) compared with controls. The risk of fracture in GBS patients exposed to pain treatment was equivalent to risk of fracture among controls exposed to pain treatment. No association with risk of fracture was observed for GBS patients compared with controls. Only GBS patients using pain treatment had a doubled risk of fracture, but their risk was equivalent to fracture risk among controls exposed to pain treatment.
    Osteoporosis International 04/2014; · 4.04 Impact Factor
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    ABSTRACT: Total hip arthroplasty (THA) and total knee arthroplasty (TKA) are effective procedures for patients with moderate-to-severe osteoarthritis. Mortality rates after THA and TKA may have changed because of new surgical techniques, improvement of peri- and postoperative care, and performance of surgery in older patients having multiple comorbidities. However, data on secular mortality trends are scarce. We undertook this study to evaluate mortality patterns between 1989 and 2007 in patients undergoing elective THA and TKA. In a Danish retrospective nationwide cohort study, 71,812 patients who underwent THA and 40,642 patients who underwent TKA were identified between January 1989 and December 2007. All-cause and disease-specific mortality was assessed, stratified by calendar periods. Using Cox proportional hazards models, relative risks (RRs) of mortality were calculated between different calendar periods, adjusted for age, sex, and comorbid diseases. Since the early 1990s, short-term survival following elective THA and TKA has greatly improved. Compared with the period between 1989 and 1991, 60-day mortality rates between 2004 and 2007 were substantially lower for patients undergoing THA (RR 0.40, 95% confidence interval [95% CI] 0.28-0.58) and for patients undergoing TKA (RR 0.37, 95% CI 0.21-0.67). This trend was far superior to what was seen in the general population. The decrease in mortality was greatest for deaths from myocardial infarction, venous thromboembolism, pneumonia, and stroke. Patients tended to have more presurgical comorbidity over time, and the duration of hospital stay was roughly halved. Mortality rates following elective THA and TKA have decreased substantially since the early 1990s, despite patients having more presurgical comorbidity. These findings are reassuring for patients undergoing elective THA or TKA.
    Arthritis & rheumatology (Hoboken, N.J.). 02/2014; 66(2):311-8.
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    ABSTRACT: High cancer mortality rates in low- and middle-income countries (LMICs) have raised concerns regarding access to oncology medicines. Essential medicines are those which satisfy the primary health care needs and provide a basis for public procurement or reimbursement decisions in LMICs. We explored selection of oncology medicines in LMICs through investigating national essential medicines lists (NEMLs) for cancer treatments. Recently updated NEMLs were retrieved for 76 countries. Oncology medicines were classified based on therapeutic categories. Countries were clustered based on geographic regions, income levels and burden of cancer (mortality and morbidity). Indicators of frequency (number of medicines), diversity (number of therapeutic (sub)categories) and more importantly absence were measured and compared across countries using parametric and nonparametric tests. The overall median number of oncology medicines on NEMLs was 16 (interquartile range = 23) chosen predominantly from subcategories of 'antineoplastic agents', with substantial variation across regions and income groups. Five countries did not select any oncology medicine and 68% did not have any 'hormones and related agents' on their NEMLs. Newer technologies like targeted therapies were infrequently incorporated. The cluster of countries suffering most from the burden of cancer selected more essential oncology medicines and diversified further. The observed selection of oncology essential medicines can reflect insufficiencies and inequalities in access to cancer treatments at least in the public sector of LMICs. Further resources need to be allocated from governments and international organizations to tackle the problem of access to oncology medicines in these countries.
    Annals of Oncology 01/2014; 25(1):270-6. · 7.38 Impact Factor
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    ABSTRACT: The aim of the study was to determine fracture risk in incident muscular dystrophy (MD) patients. Patients with MD are at a 1.4-fold increased risk of fracture as compared with population-based control patients. Risk further increased among elderly and female patients and among patients exposed to oral glucocorticoids. Muscular dystrophies (MDs) are inherited diseases causing muscle weakness and thereby increase the risk of falling and detrimental effects on bone. Both are recognised risk factors for fracture. Therefore, the aim of this study was to determine the hazard ratio of fracture in patients with MD. We conducted a retrospective cohort study using the UK General Practice Research Database (1987-2012). Each patient with MD was matched by year of birth, sex and practice to up to six patients without a history of MD. Outcome measure was all fractures. As compared with control patients, risk of any fracture was statistically significantly increased in MD patients (adjusted hazard ratio [AHR], 1.40; 95 % confidence interval [CI], 1.14-1.71). An increased risk of fracture was observed among MD patients with female gender (AHR, 1.78; 95 % CI, 1.33-2.40) and an increasing age as compared with control patients. Stratification to Duchenne MD showed no association with fracture, whereas risk of fracture was increased twofold among patients with myotonic dystrophy (AHR, 2.34; 95 % CI, 1.56-3.51). MD patients had an almost tripled risk of fracture when they used oral glucocorticoids in the previous 6 months as compared to non-users with MD. Patients with MD are at a 1.4-fold increased risk of fracture as compared with population-based control patients. Especially in older age groups and female gender, the fracture risk of MD versus non-MD patients is increased, whereas exposure to glucocorticoids further increased fracture risk among MD patients.
    Osteoporosis International 08/2013; · 4.04 Impact Factor
  • Christine C Gispen-de Wied, Hubertus G M Leufkens
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    ABSTRACT: Regulatory science as a discipline has evolved over the past years with the object to boost and promote scientific rationale behind benefit/risk and decision making by regulatory authorities. The European Medicines Agency, EMA, the Food and Drug Administration, FDA, and the Japanese Pharmaceutical and Medical Devices Agency, PMDA, highlighted in their distinct ways the importance of regulatory science as a basis of good quality assessment in their strategic plans. The Medicines Evaluation Board, MEB, states: 'regulatory science is the science of developing and validating new standards and tools to evaluate and assess the benefit/risk of medicinal products, facilitating sound and transparent regulatory decision making'. Through analysis of regulatory frameworks itself and their effectiveness, however, regulatory science can also advance knowledge of these systems in general. The comprehensive guidance that is issued to complete an application dossier for regulatory product approval has seldomly been scrutinized for its efficiency. Since it is the task of regulatory authorities to protect and promote public health, it is understood that they take a cautious approach in regulating drugs prior to market access. In general, the authorities are among the first to be blamed if dangerous or useless drugs were allowed to the market. Yet, building a regulatory framework that is not challenged continuously in terms of deliverables for public health and cost-effectiveness, might be counterproductive in the end. Regulatory science and research can help understand how and why regulatory decisions are made, and where renewed discussions may be warranted. The Dutch Medicines Evaluation Board (MEB) supports regulatory science as an R&D activity to fuel primary regulatory processes on product evaluation and vigilance, but also invests in a 'looking into the mirror' approach. Along the line of the drug life-cycle, publicly available data are reviewed and their regulatory impact highlighted. If made explicit, regulatory research can open the door to evidence based regulatory practice and serve the regulator's contribution to innovative drug licensing today.
    European journal of pharmacology 07/2013; · 2.59 Impact Factor
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    ABSTRACT: Marketing authorization application dossiers of 17 orphan drugs (ODs) and 51 non-ODs evaluated by the European Medicines Agency (EMA) in the period 2009-2010 were compared. We aimed to identify whether any differences existed between ODs and non-ODs in number and type of deficits brought forward during the EMA review, regarding the clinical development plan, clinical outcome and medical need and studied whether these deficits were similarly associated with marketing approval in the EU. In 71% of the ODs dossiers and 65% of the non-ODs dossiers marketing approval was granted. Differences in deficits were found, but similarities in the way ODs and non-ODs were reviewed and marketing approval decisions were taken, underline that regulatory standards are equally high.
    Drug discovery today 07/2013; · 6.63 Impact Factor
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    ABSTRACT: OBJECTIVES:Gastrointestinal (GI) bleeding may impose a serious threat in patients undergoing total hip or knee replacement (THR/TKR). The objectives of this study are to evaluate the timing of GI bleeding following THR/TKR and to determine the effect modification by proton pump inhibitor (PPI) use.METHODS:In a nationwide Danish cohort study, we selected all patients with a primary THR/TKR between 1998 and 2007 (n=95,115). Three control subjects without THR/TKR were matched by age, sex, and region. We calculated disease and medication adjusted (adj.) Hazard ratios (HRs) for GI bleeding with THR/TKR vs. controls. PPI use was assessed in the previous 3 months (in a time-dependent manner).RESULTS:We identified a 6-fold increased risk of GI bleeding during the first 2 weeks following THR (adj. HR, 6.02; 95% confidence interval (CI), 4.06-8.92) and a 2.3-fold increased risk for TKR patients (adj. HR, 2.30; 95% CI, 1.17-4.54), both vs. matched controls. The elevated risk lasted longer in THR patients (12 weeks) as compared with TKR patients (6 weeks). PPI use lowered the HR for GI bleeding by 74% during the first 6 weeks following THR, but not TKR.CONCLUSIONS:This study demonstrated an increased risk of GI bleeding during the first 2 weeks following THR (6-fold) and TKR (2.3-fold), and remained increased for up to 6 (TKR) to 12 weeks (THR) after surgery. PPI use substantially lowered this elevated risk in THR patients, but not in TKR patients.Am J Gastroenterol advance online publication, 30 April 2013; doi:10.1038/ajg.2013.108.
    The American Journal of Gastroenterology 04/2013; · 7.55 Impact Factor
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    ABSTRACT: There are concerns that metal-on-metal hip implants may cause cancer. The objective of this study was to evaluate patterns and timing of risk of cancer in patients with metal-on-metal total hip replacements (THR). In a linkage study between the English National Joint Registry (NJR) and the Clinical Practice Research Datalink (CPRD), we selected all THR surgeries (NJR) between 2003 and 2010 (n = 11,540). THR patients were stratified by type of bearing surface. Patients were followed up for cancer and Poisson regression was used to derive adjusted relative rates (RR). The risk of cancer was similar in patients with hip resurfacing (RR 0.69; 95% Confidence Interval [CI] 0.39-1.22) or other types of bearing surfaces (RR 0.96; 95% CI 0.64-1.43) compared to individuals with stemmed metal-on-metal THR. The pattern of cancer risk over time did not support a detrimental effect of metal hip implants. There was substantial confounding: patients with metal-on-metal THRs used fewer drugs and had less comorbidity. Metal-on-metal THRs were not associated with an increased risk of cancer. There were substantial baseline differences between the different hip implants, indicating possibility of confounding in the comparisons between different types of THR implants.
    PLoS ONE 01/2013; 8(7):e65891. · 3.73 Impact Factor
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    ABSTRACT: BACKGROUND AND PURPOSE: Stroke is a potentially fatal complication of total hip replacements (THR). However, timing of stroke in THR patients compared with matched controls and influence of drug use remain unknown. The objective of this study was to determine timing of stroke in patients with THR compared with matched control subjects. METHODS: A nationwide cohort study was conducted within the Danish registers (1998-2007). Included patients were those with a primary THR in the study period (n=66 583) and were matched by age, sex, and region to three referent subjects without THR or total knee replacements. Time-dependent Cox models were used to derive hazard ratios and were adjusted for disease history and drug use. RESULTS: A 4.7-fold increased risk of ischemic stroke (adjusted hazard ratio, 4.69; 95% CI, 3.12-7.06), and a 4.4-fold increased risk of hemorrhagic stroke (adjusted hazard ratio, 4.40; 95% CI, 2.01-9.62) were found within 2 weeks following THR, compared with matched controls. The risk remained elevated during the first 6 postoperative weeks for ischemic stroke, and the first 12 weeks for hemorrhagic stroke. Outpatient antiplatelet drug use lowered the 6-week hazard ratios for ischemic stroke by 70%, although not affecting risk of hemorrhagic stroke. CONCLUSIONS: This study shows, that THR patients have a 4.7-fold increased risk of ischemic stroke, and a 4.4-fold increased risk of hemorrhagic stroke during the first 2 weeks postsurgery. Risk assessment of stroke in individual patients undergoing THR (ie, evaluate other risk factors for stroke) should be considered during the first 6 to 12 weeks.
    Stroke 11/2012; · 6.16 Impact Factor
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    ABSTRACT: Background: Anticoagulation control is often summarised using the percentage of time spent in therapeutic range (TTR). This method does not describe the timing and severity of fluctuations in the International Normalised Ratio (INR). Objective: To evaluate whether the TTR method can be improved by considering the patterns of INR over time. Methods: The cohort included adults aged 40+ years with atrial fibrillation (AF) and laboratory records of INR as recorded in the UK Clinical Practice Research Datalink. Statistical clustering techniques based on simple INR measures were used to describe the patterns of INR. Nested case-control studies calculated the odds ratios (ORs) for the risk of stroke, bleeding and mortality with TTR and different INR patterns. It was also evaluated whether cluster analyses improved the prediction of outcomes over TTR. Results: 27,381 patients were studied with a mean age of 73. The OR for mortality was 3.76 (95% confidence interval [CI] 3.03-4.68) in patients with <30% TTR compared to patients with 100% TTR. INR patterns were found to be best described by six different clusters. The cluster with the most unstable pattern was associated with the largest risk of mortality (OR 10.7, 95% CI 8.27-13.85) and stroke (OR 3.42, 95% CI 2.08-5.63). INR measures that predicted death independent of TTR included absolute difference between two subsequent INR measurements and change relative to the mean over time. Conclusion: Cluster analysis of INR patterns improved prediction of clinical outcomes over TTR and may help to identify warfarin users who need additional anticoagulation monitoring. © 2012 International Society on Thrombosis and Haemostasis.
    Journal of Thrombosis and Haemostasis 10/2012; · 6.08 Impact Factor
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    ABSTRACT: With the European economy in the midst of the deepest recession since the 1930s and countries struggling to weigh up national and community interests, one may overlook accomplishments made in other areas of the European co-operation. Since the start of the European Union (EU) medicines approval system in 1995, the European regulatory environment has faced many challenges, but also made ample progress. Significant achievements are seen in unifying and improving regulatory practices, streamlining the way of bringing medicinal products to the clinic, thereby improving that new medicines become available to patients in the EU in an harmonized and evidence-based way.[1, 2] With the European Medicines Agency (EMA) coordinating a wide array of regulatory procedures, EU member states are contributing in many ways to the regulatory network, e.g. as rapporteur of individual dossiers, by work-sharing, guideline development, and cross learning. Recently, both the EMA and the Heads of Medicines Agencies (HMA) published their future strategy papers (i.e. European Medicines Agency Road Map to 2015: The Agency's contribution to Science, Medicines, Health and the HMA; A Strategy for the Heads of Medicines Agencies 2011-2015), aiming at strengthening the European regulatory network and its contribution to patients' access to medicinal products, public health and innovation.[3, 4].
    British Journal of Clinical Pharmacology 10/2012; · 3.58 Impact Factor
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    ABSTRACT: BACKGROUND Limited evidence suggests that the risk of acute myocardial infarction (AMI) may be increased shortly after total hip replacement (THR) and total knee replacement (TKR) surgery. However, risk of AMI in these patients has not been compared against matched controls who have not undergone surgery. The objective of this study was to evaluate the timing of AMI in patients undergoing THR or TKR surgery compared with matched controls. METHODS Retrospective, nationwide cohort study within the Danish national registries. All patients who underwent a primary THR or TKR (n = 95 227) surgery from January 1, 1998, through December 31, 2007, were selected and matched to 3 controls (no THR or TKR) by age, sex, and geographic region. All study participants were followed up for AMI, and disease- and medication history-adjusted hazard ratios (HRs) were calculated. RESULTS During the first 2 postoperative weeks, the risk of AMI was substantially increased in THR patients compared with controls (adjusted HR, 25.5; 95% CI, 17.1-37.9). The risk remained elevated for 2 to 6 weeks after surgery (adjusted HR, 5.05; 95% CI, 3.58-7.13) and then decreased to baseline levels. For TKR patients, AMI risk was also increased during the first 2 weeks (adjusted HR, 30.9; 95% CI, 11.1-85.5) but did not differ from controls after the first 2 weeks. The absolute 6-week risk of AMI was 0.51% in THR patients and 0.21% in TKR patients. CONCLUSIONS Risk of AMI is substantially increased in the first 2 weeks after THR (25-fold) and TKR (31-fold) surgery compared with controls. Risk assessment of AMI should be considered during the first 6 weeks after THR surgery and during the first 2 weeks after TKR surgery.
    Archives of internal medicine 07/2012; 172(16):1229-35. · 11.46 Impact Factor
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    ABSTRACT: To examine the risk of fracture in patients with multiple sclerosis (MS) compared with population-based controls. A population-based cohort study was performed in the Dutch PHARMO Record Linkage System (1998-2008). Patients with MS (n = 2,415) were matched by year of birth, sex, and practice to up to 6 patients without MS (controls). We used Cox proportional hazards models to estimate the hazard ratio (HR) of fracture in MS. Time-dependent adjustments were made for age, history of disease, and drug use. During follow-up, there were 59 fractures among patients with MS (2.4%) and 227 fractures among controls (1.8%). Patients with MS had a 1.7-fold increased risk of osteoporotic fracture (HR 1.73 [95% confidence interval (CI) 1.18-2.53]) and a 4-fold increased risk of hip fracture (HR 4.08 [95% CI 2.21-7.56]). The risk of osteoporotic fracture was significantly greater for patients with MS who had been prescribed antidepressants (HR 3.25 [95% CI 1.77-5.97]) or hypnotics/anxiolytics (HR 3.40 [95% CI 2.06-5.63]) in the previous 6 months, compared with controls. Increased awareness of the risk of hip fracture is warranted in patients with MS, especially in those who have recently been prescribed antidepressants or hypnotics/anxiolytics.
    Neurology 05/2012; 78(24):1967-73. · 8.25 Impact Factor
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    ABSTRACT: This study was aimed at assessing the extent of safety learning from data pertaining to other drugs of the same class. We studied drug classes for which the first and second drugs were centrally registered in the European Union from 1995 to 2008. We assessed whether adverse drug reactions (ADRs) associated with one of the drugs also appeared in the Summary of Product Characteristics (SPC) of the other drug, either initially or during the postmarketing phase. We identified 977 ADRs from 19 drug pairs, of which 393 ADRs (40.2%) were listed in the SPCs of both drugs of a pair. Of these 393 that were present in both SPCs of a drug pair, 241 (61.3%) were present when the drug entered the market and 152 (30.7%) appeared in the postmarketing phase. The mention of ADRs in the SPCs of both same-class drugs in the postmarketing phase was associated with type A ADRs, marketing in the same regulator country, a longer time interval between entry into the market by the two drugs, and an earlier date of ADR. Although there appears to be some degree of safety learning from same-class drugs, there is still room for improvement, possibly by increasing proactive risk management.
    Clinical Pharmacology &#38 Therapeutics 03/2012; 91(5):872-80. · 6.85 Impact Factor
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    ABSTRACT:   Multiple sclerosis (MS) has been associated with increased mortality rates. However, influence of lifestyle parameters remains unknown, and inconsistencies exist regarding findings for causes of death.   We conducted a population-based cohort study using the General Practice Research Database, Hospital Episode Statistics, and national death certificates (January 2001 through March 2008). To each patient with MS (n = 1270), up to six referent subjects without MS were matched by age, gender, and practice. Cox proportional hazards models were used to estimate mortality rate ratios (HRs).   Patients with MS had a 3.5-fold increased mortality rate for all-cause mortality, compared with referent subjects (HR 3.51, 95% CI 2.63-4.69). The rate further increased amongst current smokers (HR 6.72, 95% CI 4.16-10.87) (but not in ex-smokers) and subjects with a body mass index of <20 kg/m(2) (HR 6.67, 95% CI 3.50-12.73). The HR was highest for infectious/respiratory-related deaths (HR 7.69, 95% CI 4.92-12.02) and was significantly increased for deaths related to cardiovascular diseases (2.4-fold) and cancer (1.9-fold), but not for accidents and suicide related deaths.   British patients with MS have a 3.5-fold increased mortality rate compared with the general population. Smoking and respiratory diseases are major (potentially preventable) factors related to increased mortality rate amongst patients with MS.
    European Journal of Neurology 02/2012; 19(7):1007-14. · 4.16 Impact Factor
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    ABSTRACT: Achtergrond: Veel mensen met angst- of slaapstoornissen krijgen van hun dokter een benzodiazepine voorgeschreven. Langdurig gebruik zorgt echter voor gewenningsproblemen en hoge maatschappelijke kosten. Om deze effecten te beperken heeft het ministerie van VWS de vergoeding van benzodiazepinen per 1 januari 2009 uit de basisverzekering gehaald. Sindsdien betalen de meeste gebruikers de kosten van benzodiazepinen zelf. Methode: In de gegevens van het Landelijk Informatie Netwerk Huisartsenzorg (LINH) keken wij hoeveel mensen tussen januari 2007 en december 2009 voor het eerst de diagnose slaap- en angststoornissen kregen bij de huisarts. Daarna onderzochten wij hoeveel recepten voor een benzodiazepine deze patiënten kregen en hoeveel van hen er ook weer mee stopten, en zo ja wanneer. Ook keken wij naar het aantal recepten voor een selectieve serotonineheropnameremmer (SSRI). Resultaten: Van de 13.596 patiënten die aan de voorwaarden voldeden had iets meer dan de helft een angststoornis, de anderen hadden een slaapprobleem. In 2009 kregen minder mensen de diagnose slaap- of angststoornis te horen dan in 2008. Ook het benzodiazepinegebruik daalde. Van de patiënten met slaapstoornissen kreeg 67,0% in 2008 een benzodiazepine voorgeschreven, versus 59,1% in 2009, en voor angststoornissen waren deze percentages 33,7% in 2008 versus 30,1% in 2009. Ook het aantal mensen dat meer dan één recept kreeg, daalde: voor slaapproblemen van 42,6% naar 35,0%, voor angststoornissen van 42,6% naar 36,4%. Slechts een klein (maar toenemend) aantal angstpatiënten stapte over op een SSRI: 0,3% in 2009 tegenover 0,1% in 2008. Conclusie: Het reduceren van de vergoeding heeft geleid tot een lichte daling in het aantal diagnoses, voorschriften en vervolgrecepten. Deze daling was groter bij slaapproblemen dan bij angststoornissen. De uitkomsten ondersteunen het beleid van de regering en laten zien dat er ruimte bestaat om het gebruik van deze geneesmiddelen te reduceren. (aut.ref.)
    Huisarts en wetenschap 01/2012;
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    ABSTRACT: This study aimed to provide an up-to-date description as well as comparative analysis of the national characteristics of pharmaceutical external price referencing (EPR) in Europe. Review of the country-specific PPRI (Pharmaceutical Pricing and Reimbursement Information) Pharma Profiles written by representatives of the PPRI Network. The Profiles were analysed according to predefined criteria. Of 28 analysed European countries 24 applied EPR in 2010. The majority of countries have statutory rules to implement EPR. Most countries had less than 10 countries in their reference baskets. Higher income countries tend to include higher income countries in their basket, whereas lower income countries refer to lower income countries. Taking the average price of all countries in the basket as the basis to calculate the national price was the most common strategy (n=8). The methodology of EPR has changed in most European countries over the past 10 years (n=19). EPR is a widely used pricing policy in Europe and is still actively used as well as adjusted by national authorities. However, we still see room for improvement by implementing more detailed legislations in terms of the revision of prices and by identifying alternative countries in case a product is not on the market. We also see the need for formal information sharing (e.g. congresses dedicated to pricing strategies and systems) with other public pricing authorities to learn about the different EPR methodologies as well as the national experiences. These congresses might also give room to better understand national pricing methods including discussions on possible limitations of these pricing methods.
    Health Policy 01/2012; 104(1):50-60. · 1.51 Impact Factor
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    ABSTRACT: The majority of knee arthroplasties (KAs) are performed in patients with osteoarthritis (OA). Although bone mass may be increased in these patients, subjects with knee OA may have an increased risk of hip fracture, possibly due to an increased severity of falls. However, in patients with KAs, risk of hip fracture has not been studied extensively. We evaluated the association between KAs and hip fracture risk in a population-based case-control study using the Dutch PHARMO Record Linkage System (1991-2002, n = 33,104). Cases were patients with a first admission for hip fracture; controls were matched by age, gender, and geographic location. Neither group had a previous history of fracture. Time since first KA was calculated. Analyses were adjusted for disease and drug history. A 54% increased hip fracture risk was found in patients who underwent KA (adjusted [adj.] OR = 1.54, 95% CI 1.19-2.00). We found a strong effect modification by age in these patients: the youngest patients (aged 18-70 years) were at more increased risk for hip fracture (adj. OR = 2.76, 95% CI 1.16-6.59), while we could not detect a statistical increase in patients aged >80 years. Furthermore, the association tended to be greater during the first few years after surgery, although it did not reach statistical significance. We found that KAs are associated with a 54% increased risk of hip fracture, in particular among adult patients aged <71 years old. Fracture risk assessment could be considered in patients who are about to undergo a KA.
    Calcified Tissue International 12/2011; 90(2):144-50. · 2.50 Impact Factor

Publication Stats

3k Citations
615.47 Total Impact Points


  • 1993–2014
    • Universiteit Utrecht
      • • Division of Pharmacoepidemiology and Pharmacotherapy
      • • Utrecht Institute for Pharmaceutical Sciences
      Utrecht, Utrecht, Netherlands
  • 2013
    • Medicines Evaluation Board, Netherlands
      Utrecht, Utrecht, Netherlands
  • 2002–2012
    • University Medical Center Utrecht
      • Julius Center for Health Sciences and Primary Care
      Utrecht, Provincie Utrecht, Netherlands
    • Netherlands Institute for Space Research, Utrecht
      Utrecht, Utrecht, Netherlands
  • 2008
    • Medicines and Healthcare products Regulatory Agency (MHRA)
      Londinium, England, United Kingdom
  • 2002–2007
    • TweeSteden Ziekenhuis
      Tilburg, North Brabant, Netherlands
  • 2002–2006
    • University of Southampton
      • MRC Lifecourse Epidemiology Unit
      Southampton, England, United Kingdom
  • 2005
    • University of Nottingham
      • School of Community Health Sciences
      Nottingham, ENG, United Kingdom
  • 2004
    • SWOV Institute for Road Safety Research
      Leyden, South Holland, Netherlands
  • 2003
    • Pharmo Institute for Drug Outcomes Research
      Utrecht, Utrecht, Netherlands
    • Altrecht GGZ
      Utrecht, Utrecht, Netherlands
  • 1999
    • Maastricht University
      • Department of Epidemiology
      Maestricht, Limburg, Netherlands
  • 1995
    • Erasmus Universiteit Rotterdam
      • Department of Internal Medicine
      Rotterdam, South Holland, Netherlands